title: Sublingual therapeutic immunization with a polyvalent bacterial preparation in patients with recurrent respiratory infections: immunomodulatory effect on antigen-specific memory CD4+ T cells and impact on clinical outcome.
abstract: Recurrent respiratory tract infections (RRTIs) are common clinical conditions in individuals with alterations of the immune function. A prospective open pilot study in a cohort of patients with RRTIs has been performed to assess whether sublingual immunization with a polyvalent bacterial vaccine could exert an immunomodulatory effect on the antigen-specific immunological responses and have an impact on the clinical outcome. Seventeen patients with RRTIs were recruited. An oral polyvalent bacterial preparation (Bactek®) was administered to all patients daily for 6 months. Immunological assessment was performed at baseline and at the end of immunization. Immunological measurements included: T cell-specific proliferations of CD3+CD4+ and CD3+CD8+ to Bactek® antigens, total immunoglobulin levels, antibodies to pneumococcal polysaccharide and tetanus toxoid and B, T and natural killer (NK) cell subsets. There was a significant increase in the proliferative capacity of CD3+CD4+ T cells specific to Bactek® antigens at month 6 in comparison to baseline (P < 0·0001). A significant increase in total CD3+ T cells was also observed (P < 0·05). No significant differences were observed between baseline and month 6 in levels of total immunoglobulins, specific antibodies and B, T or NK cell subsets. A significant reduction in the patient's rate of RRTIs was observed compared with 1 year prior to initiation of therapy (P < 0·0001). The results demonstrate that long-term administration of a sublingual polyvalent bacterial preparation in patients with RRTIs exerts an immune stimulating effect on CD4+ T helper cell responses to bacterial antigens which could be associated with clinical benefit.
authors.affiliation: Clinical Immunology Unit, Immunology, Department, Hospital General Universitario, Gregorio Marañón, Departamento de Microbiología I, Universidad Complutense de Madrid, Spain. dalecsan.hgugm@salud.madrid.org
authors.forename: D
authors.initials: D
authors.lastname: Alecsandru
authors.forename: L
authors.initials: L
authors.lastname: Valor
authors.forename: S
authors.initials: S
authors.lastname: Sánchez-Ramón
authors.forename: J
authors.initials: J
authors.lastname: Gil
authors.forename: J
authors.initials: J
authors.lastname: Carbone
authors.forename: J
authors.initials: J
authors.lastname: Navarro
authors.forename: J
authors.initials: J
authors.lastname: Rodríguez
authors.forename: C
authors.initials: C
authors.lastname: Rodríguez-Sainz
authors.forename: E
authors.initials: E
authors.lastname: Fernández-Cruz
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D000368:Aged; D001402:B-Lymphocytes / Q000187:drug effects / Q000276:immunology; D001424:Bacterial Infections / Q000097:blood / Q000188:drug therapy / Q000276:immunology* / Q000382:microbiology; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000276:immunology*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007114:Immunization / Q000379:methods*; D007136:Immunoglobulins / Q000097:blood / Q000276:immunology; D007694:Killer Cells, Natural / Q000187:drug effects / Q000276:immunology; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012008:Recurrence; D012141:Respiratory Tract Infections / Q000097:blood / Q000188:drug therapy / Q000276:immunology*; D013601:T-Lymphocytes / Q000187:drug effects / Q000276:immunology; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001428:Bacterial Vaccines; D007136:Immunoglobulins